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The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.

Dynamic tilt in space mechanical wheelchair which offers adjustability to redistribute the body weight for optimal positioning. The tilting is operated by the care-giver in the back handles of the chair. The Capella/Capella 45 can accommodate different size occupants. The seat width and depth can be ordered in several sizes. The Capella/Capella 45 is constructed of a rigid, aluminum frame with anti-tippers and the ability to tilt and manual recline. Depending on the seat depths, it has a capacity to support a human weight of 350lbs (250lbs Capella45). One gas spring is used to lift an ddecline the seat and back to the tilting positions in the Capella 45. And the Capella uses two gas springs. The gas spring(s) are connected by cables to levers on the push bar so that they can be locked and unlocked by the caregiver.

The provided text is a 510(k) summary for a mechanical wheelchair, not a medical imaging or AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) are not applicable to this type of device submission.

The acceptance criteria for this device, a mechanical wheelchair, are primarily based on ensuring its safety and effectiveness through compliance with recognized standards and comparison to a predicate device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Future Mobility Healthcare Inc. Capella/Capella 45) demonstrates substantial equivalence to the predicate device (PDG Inc. Fuze T20) by meeting or exceeding similar performance characteristics and conforming to relevant safety standards.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is an engineering and performance testing study conducted against harmonized standards. The submission states:

• "The Capella/Capella45 has been designed and tested according to the ANSI/RESNA WC/Vol.1. All results are satisfactory and meet the standards indicated from ANSI/RESNA WC/Vol.1"
• "All chairs passed safety, stability, fatigue and strength tests."
• "Each wheel size has been evaluated by Future Mobility for stability and strength with satisfactory results."
• "Each caster size has been evaluated by Future Mobility."
• The conclusion explicitly states: "Future Mobility Healtheare Capella Dynamic Tilt mechanical wheelchair was developed in accordance with ISO 7176, parts 1, 5, 7, 8, 11, 13, and 15. It is the conclusion that the Future Mobility HealthCare Capella wheelchair is safe and effective, as well as substantially equivalent to the legally marketed device identified as the predicate devices."

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a number of devices. It refers to "All chairs" and "Each wheel size" and "Each caster size," implying that representative samples of the manufactured devices and their components were tested. For a mechanical device of this nature, testing protocols usually involve a predefined number of units or components to demonstrate reliability and meet engineering standards.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by Future Mobility Healthcare Inc. or a contracted testing facility, likely in the country of origin (Canada, based on the submitter's address). This is a prospective evaluation of the newly designed device's performance against established physical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. "Ground truth" in the context of mechanical device testing typically refers to the objective physical measurements and performance metrics defined by the specific engineering standards (ANSI/RESNA WC/Vol.1, ISO 7176 parts). Experts are involved in setting these standards and designing the tests, but not in establishing "ground truth" for individual test results in the same way as in a diagnostic study.

4. Adjudication method for the test set

• Not applicable. Performance is measured against objective, quantitative engineering specifications, not subjective interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI or diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI or diagnostic device. Performance is inherently "standalone" in that the wheelchair's mechanical properties are tested independently of a human user, though it's designed for human interaction.

7. The type of ground truth used

• Engineering Standards / Objective Performance Metrics: The "ground truth" is defined by the objective pass/fail criteria and quantitative limits set forth in the referenced international and national standards: ANSI/RESNA WC/Vol.1 and ISO 7176 (parts 1, 5, 7, 8, 11, 13, and 15). These standards cover aspects like static stability, strength, fatigue, dimensions, and material properties.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model requiring a training set. The "design and development" process would involve iterative prototyping and testing, but not in the sense of a machine learning training set.

9. How the ground truth for the training set was established

• Not applicable. No training set is used for this type of device.

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The Future Mobility Healthcare Inc. Super Chair for Kids by Orion Wheelchair is intended to provide mobility to persons limited to a sitting position.

The ORIONII, Zippie TS and Super Chair for Kids by Orion tilt in space wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of mechanical steel frames for use by patients weighing up to 150 lbs.

The provided text describes a 510(k) premarket notification for a medical device, the "Super Chair for Kids by Orion Tilt in Space mechanical wheelchair." This is a mechanical wheelchair, not an AI/ML-driven diagnostic or medical device that typically requires extensive acceptance criteria, performance studies, or ground truth establishment in the way the prompt describes.

The 510(k) submission process for this type of device focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance metrics through clinical trials or complex diagnostic studies. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this specific submission.

Here's an analysis based on the provided document and the nature of a mechanical wheelchair 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For a mechanical wheelchair, "acceptance criteria" primarily relate to safety standards and functional equivalence to predicate devices, rather than diagnostic accuracy metrics.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. This is a mechanical device, not a diagnostic algorithm. The "testing" involved demonstrating compliance with international standards (ISO 7176) and technical equivalence to existing devices. This typically involves engineering testing and comparison of specifications, not a "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. The concept of "ground truth" as it applies to diagnostic accuracy from expert interpretation is not relevant for a mechanical wheelchair. Device functionality and safety are assessed against engineering standards and comparison with predicate devices.

4. Adjudication Method for the Test Set:

• Not Applicable. No human-interpreted "test set" in the diagnostic sense was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a mechanical wheelchair, not an AI-driven diagnostic tool. No human readers or AI assistance are involved in its primary function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used:

• For this type of device, the "ground truth" (or equivalent) is established by engineering standards compliance (ISO 7176) and the established safety and effectiveness of the legally marketed predicate devices. The claim of substantial equivalence is the "proof."

8. The Sample Size for the Training Set:

• Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is fundamentally a technical comparison and demonstration of compliance with recognized standards.

• Nature of the "Study": This was not a clinical trial in the traditional sense, but rather a bench and engineering testing verification combined with a comparative analysis against predicate devices.
• Methodology:
  1. Technical Specification Comparison: The manufacturer compared the design, materials, intended use, and functional characteristics of the "Super Chair for Kids by Orion" to the predicate devices (Zippie TS and ORION II).
  2. Standards Compliance Testing: The device was developed and tested in accordance with ISO 7176 standards (parts 1, 5, 7, 8, 11, and 19). These standards cover various aspects of wheelchair performance, safety, and durability (e.g., dimensions, static strength, impact strength, fatigue strength, and securement in motor vehicles). The report explicitly states, "Future Mobility HealthCare Super Chair for Kids by Orion folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1. 5. 7. 8. 11 and 19."
  3. Demonstration of Substantial Equivalence: The manufacturer argued that the device shared the same indications for use, similar key technical characteristics, similar operational modes (manual, self-propelled, attendant-propelled), similar construction (steel frames), equivalent weight capacity (up to 150 lbs), and met the same safety standards for motor vehicle transport tie-down systems (ANSI/RESNA WC/Vol.1 Annex A Section 19) as the predicate devices.
• Conclusion: Based on this comparison and compliance with international standards, it was concluded that the "Super Chair for Kids by Orion" is safe and effective and substantially equivalent to the identified predicate devices. The FDA's 510(k) clearance (K103073) formally acknowledges this determination of substantial equivalence.

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The Future Mobility Healthcare Inc. Galaxy Lite Wheelchair is intended to provide mobility to persons limited to a sitting position.

The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames for use by patients weighing up to 250 lbs.

The provided document is a 510(k) summary for the Future Mobility Healthcare Inc. Galaxy Lite manual wheelchair. This type of medical device submission does not typically involve the kind of performance studies or acceptance criteria you've requested that are common for AI/ML or diagnostic devices.

Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, design characteristics, and compliance with recognized standards.

Therefore, I cannot provide the specific details you've asked for regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance, as these are not relevant to this type of device submission.

Here's what I can extract from the document regarding the device and its compliance:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, as would be seen for AI/ML or diagnostic devices. Instead, the "acceptance criteria" are implied by adherence to established standards and similarity to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided because it's not applicable to a 510(k) submission for a mechanical wheelchair based on substantial equivalence and standards compliance. There isn't a "test set" in the sense of a dataset for algorithmic evaluation. The "testing" refers to physical product testing against ISO standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for a test set is specific to diagnostic or AI/ML performance evaluation, not to a mechanical device's substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This type of study is for evaluating human-AI interaction in diagnostic tasks, which is not relevant to a manual wheelchair.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. There is no algorithm in this mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this device, "ground truth" would relate to the physical properties and performance of the wheelchair as measured against engineering standards (e.g., stability, strength), rather than a diagnostic outcome.

8. The sample size for the training set

Not applicable. This device does not use a "training set" for an algorithm.

9. How the ground truth for the training set was established

Not applicable.

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To provide mobility to persons limited to a sitting position.

The ORION II Medical device and the Orion (Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar performance. The modifications consist of wider frames with a reinforced design to withstand the higher weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32".

The provided text describes a 510(k) summary for a medical device, specifically a modified manual wheelchair (ORION II Heavy Duty). It focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, design characteristics, and compliance with recognized standards.

However, the provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI/algorithm-driven device. The submission is for a mechanical wheelchair, and the "study" referred to is the demonstration of compliance with ISO 7176 standards for wheelchairs.

Therefore, most of the requested information regarding AI/algorithm performance (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this document.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission is for a mechanical wheelchair, not an AI/algorithm-driven device that would typically have a "test set" in the context of data evaluation. The "test" involved demonstrating compliance with ISO standards through engineering design and potentially physical testing, not data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth in the context of expert consensus is not relevant for this mechanical device submission. Compliance with ISO standards likely involves engineers and quality assurance personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are not relevant for this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a mechanical device, not an AI-assisted diagnostic or treatment system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For compliance with ISO 7176 standards, the "ground truth" would be the engineering specifications, test protocols, and performance requirements outlined in those standards. The device's performance is measured against these established benchmarks.

8. The sample size for the training set

• Not applicable. This is a mechanical device.

9. How the ground truth for the training set was established

• Not applicable. This is a mechanical device.

Summary of the "Study" (Compliance Demonstration):

The "study" or demonstration of the device meeting acceptance criteria for this mechanical wheelchair involves:

• Engineering Design and Analysis: The modifications to the ORION II (wider frames, reinforced design) were specifically engineered to allow for higher weight capacities (350lbs and 500lbs) compared to the predicate device's 250lbs.
• Compliance with Recognized Standards: The core of the demonstration is the declaration that the device was "developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11." These are international standards for wheelchairs that specify requirements and test methods for aspects such as:
  • ISO 7176-1: Determination of static stability
  • ISO 7176-5: Determination of dimensions, mass, and manoeuvring space
  • ISO 7176-7: Seating and wheel dimensions
  • ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths
  • ISO 7176-11: Test dummies
    This compliance indicates that the wheelchair underwent various tests (e.g., static stability, strength, fatigue) and met the specified performance criteria outlined in these standards for its stated weight capacities.
• Substantial Equivalence Argument: The entire submission serves as a "study" to prove substantial equivalence to the predicate device (ORION II Wheelchair K061010) by comparing indications for use, technological characteristics, and demonstrating that any differences (like increased weight capacity) do not raise new questions of safety or effectiveness, particularly given the compliance with relevant ISO standards.

In essence, the "study" for this mechanical device is a combination of design validation, engineering testing, and adherence to established international performance and safety standards, rather than a clinical trial or algorithmic performance evaluation.

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The Future Mobility HealthCare Inc. Orion II Wheelchair is intended to provide mobility to persons limited to a sitting position.

The Future Mobility HealthCare Orion II wheelchair is a compact tilt-in-space wheelchair offering 45° of tilt, 30° of recline and adjustable seat-to-floor heights of 12 3/4' to 19". It consists of rigid, mechanical, steel frame and upholstery that meets the California Technical Bulletin CAL 117 standard for flame retardant. It has two rear wheels (12", 20", 22" or 24" in diameter) and two front casters (4", 5", 7" or 8" in diameter) for turning and maneuverability.

This submission for the Future Mobility HealthCare Inc. Orion II Wheelchair is a 510(k) premarket notification. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of detailed study data you're asking for in points 2-9.

Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable to this type of regulatory submission for this device. The document provided does not contain a study of the type you describe.

Here's an analysis based on the information provided, fitting it to your requested structure where possible, and noting where the information is absent or not applicable due to the nature of a 510(k) for a mechanical wheelchair:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of a mechanical wheelchair, "acceptance criteria" are generally tied to demonstrating equivalence in design, materials, and intended use as compared to a predicate device. Performance is assessed through compliance with recognized standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This 510(k) summary does not describe a clinical performance study with a test set of patients or data in the way you might find for an AI/diagnostic device. The "test" for a mechanical wheelchair 510(k) involves demonstrating mechanical equivalence and adherence to engineering standards (like ANSI/RESNA, ISO 7176).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. As there is no clinical performance study with "ground truth" to establish for a mechanical wheelchair 510(k). Ground truth in this context would typically relate to a diagnostic outcome, which is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. MRMC studies are relevant for diagnostic/AI devices. This is a mechanical wheelchair.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a mechanical wheelchair, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable / Not provided in this context. The "ground truth" for a mechanical device's safety and effectiveness relies on engineering standards, material specifications, and mechanical testing to ensure the components perform as intended (e.g., tilt mechanism holds weight, frame doesn't fail). These tests are typically outlined in the full 510(k) submission but are not detailed in this summary.

8. The sample size for the training set

• Not applicable / Not provided. As there is no "training set" for a mechanical wheelchair undergoing a 510(k) for substantial equivalence.

9. How the ground truth for the training set was established

• Not applicable / Not provided. See point 8.

Summary of the Basis for Substantial Equivalence (as reported in the document):

The Orion II Wheelchair's substantial equivalence to the Invacare Concept 45 Wheelchair is based on:

• Same Indications for Use: Both provide mobility to persons limited to a sitting position.
• Similar Key Design Technical Characteristics: Both are mechanical wheelchairs with tilt (45°) and recline (30°) capabilities, adjustable back angles, and similar seat depth and widths.
• Similar Size, Weight, and Performance: A general claim of similarity.
• Similar Materials: Both use resistance-ignitability fabric meeting California Technical Bulletin CAL 117 for flame retardant standards.
• Compliance with Standards: The Orion II was developed based on ANSI/RESNA Wheelchair Vol.1, which involves ISO 7176 standards.

The FDA's decision to clear the device (K061010) confirms their agreement that the provided information demonstrates substantial equivalence to the predicate device, allowing it to be marketed.

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